Mr. Lown, General Manager of Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA), noted that the complexity of clinical, regulatory and reimbursement dynamics can present many unforeseen business challenges to even the most experienced industry veterans. "Every phase of the technology lifecycle is becoming more interwoven and multifaceted," he said. "Given the substantial size of the device industry and the increasing concerns of rising healthcare costs, the Centers for Medicare and Medicaid Services (CMS), the U.S. Food and Drug Administration (FDA), and numerous other governmental and private stakeholders all have a seat at the table in influencing whether industry has proved safety, efficacy, and cost effectiveness over existing treatments. Although governmental and private constituents act individually for the most part, industry must execute their business strategies in an integrated fashion so that marketing claims are consistent with regulatory claims which are consistent with reimbursement coding and coverage, in order to compliantly adhere to the multiple U.S. laws of these constituents. Lastly, clinical evidence requirements are increasing on most technologies, both new and existing, thereby increasing the investment required for successful commercialization, which is putting additional strain on both companies and private investors to further invest in advancements."
MCRA was founded in 2004 and has partnered with nearly 500 clients globally to design and execute integrated product development strategies. "Since the 1960's, the orthopedic industry was focused on bringing innovation accessible to surgeons in a quick and cost efficient manner. Device companies must realize today that industry-wide evidence requirements are quickly becoming analogous to the pharmaceutical industry and for those who invest properly both value creation and risk mitigation will be the reward." Mr. Lown advised.
Full details of the proceedings of IMPLANTS 2017 are available at www.implants-event.com. For more information about MCRA go to: www.mcra.com.
About MCRA
Founded in 2004, Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA) is a leading adviser and clinical research organization to the neuro-musculoskeletal and orthopedic industry. MCRA's value lies in its industry experience and integration of five business value creators: regulatory, reimbursement, clinical research, healthcare compliance and quality assurance. MCRA's integrated approach of these key value creating initiatives provides unparalleled expertise for its clients. MCRA has offices in Washington, DC, Manchester, CT and New York, NY, and serves nearly 500 clients globally.
Contact
David W. Lown
General Manager
212.583.0250 ext. 2111
dlown@mcra.com